Senior Manager Global Site Management

Senior Manager position leading global site management and risk-based monitoring strategies for clinical trials at a biopharmaceutical company. The role involves designing monitoring approaches, overseeing CRO activities, and collaborating across functions to ensure study quality and regulatory compliance across a global clinical portfolio.

Responsibilities

• Lead development and implementation of risk-based monitoring and site management strategies for global clinical programs
• Provide oversight of CRO and FSP monitoring activities to ensure quality and compliance with study objectives
• Evaluate performance metrics and key risk indicators to identify and mitigate study risks proactively
• Establish relationships with investigator sites and partners to drive study performance and data quality
• Contribute to process improvement initiatives enhancing clinical trial delivery and operational efficiency

Requirements

• Bachelor's degree and 8+ years clinical research, operations, or site management experience
• Strong knowledge of clinical trial operations and risk-based monitoring methodologies
• Experience with Risk-Based Quality Management (RBQM) framework
• Working knowledge of ICH-GCP guidelines and regulatory requirements
• Demonstrated experience managing CROs and Functional Service Providers
• Excellent communication, collaboration, and stakeholder management skills